Feasibility, safety, and functional outcomes using the neurological controlled Hybrid Assistive Limb exoskeleton (HAL®) following acute incomplete and complete spinal cord injury – Results of 50 patients

Abstract

Objective Recent studies reveal that Hybrid Assistive Limb (HAL®) locomotion training in paraplegic patients suffering from chronic spinal cord injury (SCI) induces improvements in functional and ambulatory mobility. The purpose of this study was to determine the safety, feasibility, and functional effectiveness of HAL® locomotion training in the initial rehabilitation of acute SCI patients. This clinical trial represents the first systematic intervention worldwide for acute SCI patients using a neurologically controlled exoskeleton. Design Single center, prospective study. Setting BG University Hospital Bergmannsheil, Bochum, Germany. Participants Fifty acute SCI patients (14 women, 36 men). Interventions All participants received a daily (5 times/week) HAL® exoskeleton supported training for 12 weeks (mean amount of training sessions 60.4 ± 30.08). Outcome Measures Functional outcome for overground walking was monitored using the 10-m-walk test (10 MWT) combined with the WISCI II score, 6-minute-walk test (6 MWT) and the timed-up and go test (TUG test). Treadmill-related parameters (speed, distance and walking time) and the Lower Extremity Motor Score (LEMS) were recorded separately. Results Significant improvements were observed for HAL®-associated (walking time, distance and speed) and for functional outcomes (10 MWT, 6 MWT and TUG-test). WISCI-II-Score and the LEMS increased significantly compared with the status prior to training. Conclusion HAL® locomotion training is feasible and safe in the rehabilitation of acute SCI patients. The HAL® exoskeleton enables the patient to perform effective treadmill training and leads to improvements in functional and ambulatory mobility. However, spontaneous recovery vs training-related effects remain unclear and findings should not be extrapolated beyond the acute in-patient rehabilitation setting. Trial registration: German Clinical Trials Register identifier: DRKS00010250..